Egrifta Quality Of Life Deciding Factor In Advisory Panel's Recommendation
Improving patients' quality of life seemed to be more important than an unproven cardiovascular benefit in an FDA advisory panel's unanimous vote to recommend approval of Theratechnologies' Egrifta (tesamorelin), indicated for reduction of visceral adipose tissue in HIV patients receiving antiretroviral therapy
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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